Rheumatoid Arthritis Patients and Porphyromonas Gingivalis

Rheumatoid Arthritis Clinical Trial

Official title:

Porphyromonas Gingivalis Contribution in Rheumatoid Arthritis (RA).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905175
• Other study ID #: 1408022
• Secondary ID: 2014-A01688-39
• Status: Completed
• Start date: January 13, 2016
• Est. completion date: June 27, 2016

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rheumatoid arthritis (RA) is the most frequent joint inflammatory disease inducing joint destruction strongly correlated with anti-citrullinated protein antibodies citrullinated anti-peptide (ACPA). Precise RA etiology remained unclear with a described association between RA and periodontal disease. The missing link could be a gram-negative anaerobic bacterium called Porphyromonas gingivalis (P. gingivalis), which is heavily involved in periodontal disease and able to induce gingival citrullinated protein via an enzyme called peptidyl arginine deiminase (PAD). DNA of P. gingivalis was detected in synovial tissue and in peripheral blood mononuclear cell. To improve knowledge of P. gingivalis involvement in RA, the investigators will compare its effect on various cell type with comparison with another oral bacteria Provatella intermedia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 27, 2016
• Est. primary completion date: June 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 ans

• RA or osteoarthritis with joint surgery planned

• Informed consent approved and signed

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• blood sample

• synovial tissue
synoviocytes from synovial tissue

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of genetic signature after induction by P. gingivalis and P. intermedia on synoviocytes		day 1
Secondary	Comparison of specific transcriptome profile induced by P. gingivalis compared to P. intermedia on peripheral blood mononuclear cells (PBMC) and gingival fibroblasts		day 1
Secondary	Comparison of transcriptome profile between P. gingivalis and P. intermedia on RA synovial cells.		day 1
Secondary	Comparison of the transcriptomic profile between RA and osteoarthritis synoviocytes		day 1